Lidocaine/ Prilocaine

Registered South African indications:

• Topical anaesthesia

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy
• Breastfeeding 
• Defective glucose-6-phosphate dehydrogenase
• Hereditary or idiopathic methaemoglobinaemia
• Open wounds (excluding leg ulcers)
• Newly shaven skin
• Atopic dermatitis
• Contact with eyes 
• Impaired tympanic membrane
• Newborn infants/ infants up to 12 months (if coadministered with methaemoglobin-inducing agents)
• Preterm infants < 37 weeks 
• Children < 12 years 
• Circumcision in children

Forms avail in SA and covered in this monograph: cre, pat

Topical anaesthesia of the skin

Lidocaine/ Prilocaine
25/25 (mg/g)
25/25 (mg)

- Minor procedures

• Topical (cre): 1.5-2g/10cm², applied in a thick layer; Treatment duration: 1-5hrs
• Topical (pat): 1 or more patches, applied to selected area; Treatment duration: 1-5hrs

- Dermal surgical procedures on larger areas in a hospital setting

• Topical (cre): 1.5-2g/10cm², applied in a thick layer; Treatment duration: 2-5hrs

- Newly shaven skin of large body areas

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 1-5hrs; Max: 60g

- Male genital organs prior to injection of local anaesthetics

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 15min

- Female genital organs prior to injection of local anaesthetics

• Topical (cre): 1-2g/10cm², applied in a thick layer; Treatment duration: 60min

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Treatment area should be covered with an occlusive dressing after application of the cream

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Cream: The duration of anaesthesia after an application time of 1-2hrs is at least 2 hours after removal of the dressing

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1g corresponds to a length of extruded cream of 3.5cm

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Topical anaesthesia of the genital mucosa
- Superficial surgical procedures
- Prior to cervical curettage

• Topical (cre): Apply 5-10g to treatment area; Treatment duration: 5-10min

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The entire treatment area, including mucosal folds, should be covered by the cream

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Occlusion is not necessary

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The surgical treatment should commence immediately after removal of the cream

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Analgesia duration is 15-20 minutes

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Topical anaesthesia of leg ulcers
- To facilitate mechanical cleansing and debridement

• Topical (cre): 1-2g/10cm², applied in thick layer to the leg ulcer; Treatment duration: 30-60min; Max: 10g

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Treatment area should be covered with an occlusive dressing after application of the  cream

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Cleansing should start immediately after removal of the cream 

Paed. forms avail in SA and covered in this monograph: cre, pat 

Topical anaesthesia of the skin

Lidocaine/ Prilocaine
25/25 (mg/g)
25/25 (mg)

- Minor procedures

Between 0-3 months, < 5kg

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 1hr; Max: 1g
• Topical (pat): Not established for use

Between 3-12 months, > 5kg

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 1-4hrs; Max: 2g
• Topical (pat): 1 patch, applied to selected area; Treatment duration: 1-5hrs; Max: 2 patches 

Between 1-5 years

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 1-5hrs; Max: 10g
• Topical (pat): 1 patch, applied to selected area; Treatment duration: 1-5hrs; Max: 10 patches

Between 6-12 years

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 1-5hrs; Max: 20g
• Topical (pat): 1 patch, applied to selected area; Treatment duration: 1-5hrs; Max: 20 patches

Older than 12 years

• See adult dosage

- Prior to removal of mollusca in children with atopic dermatitis

• Topical (cre): 1g/10cm², applied in a thick layer; Treatment duration: 30min
• Topical (pat): 1 patch, applied to affected area; Treatment duration: 30min

Pregnancy

• Caution; no evidence of risk in studies
• Although topical application is associated with only a low level of systemic absorption, the use of lidocaine/prilocaine cream in pregnant women should be undertaken with care because insufficient data are available concerning the use of lidocaine/prilocaine cream in pregnant women. However, animal studies do not indicate any direct or indirect negative effects on pregnancy, embryo-foetal development, parturition or postnatal development. Reproduction toxicity has been shown with subcutaneous/intramuscular administration of high doses of lidocaine or prilocaine much exceeding the exposure from topical application
• Lidocaine and prilocaine cross the placental barrier and may be absorbed by the foetal tissues. It is reasonable to assume that lidocaine and prilocaine have been used in a large number of pregnant women and women of childbearing age. No specific disturbances to the reproductive process have so far been reported, e.g. an increased incidence of malformations or other directly or indirectly harmful effects on the foetus

Breastfeeding

• Caution
• Lidocaine and, in all probability, prilocaine are excreted into breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels. Lidocaine/prilocaine cream can be used during breastfeeding if clinically needed

Renal Impairment 

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Burning sensation
• Application site reactions
• Purpura
• Petechia

Immune, Blood and Lymphatic System Disorders

• Methaemoglobinaemia
• Hypersensitivity
• Allergic reactions 

Sensory Disorders

• Corneal irritation

• Methaemoglobin-inducing medicinal products
• Sulphonamides
• Nitrofurantoin
• Phenytoin
• Phenobarbital
• Other local anaesthetics
• Medicinal products structurally related to local anaesthetics
• Anti-arrhythmics (Class III)
• Cimetidine
• Beta-blockers

None routine. Specific cases may require

• ECG
• Serum methaemoglobinaemia concentration

Lidocaine and prilocaine are amide-type local anaesthetics. They both stabilise neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anaesthesia.

COMBINATION PREPARATIONS

Lidocaine/ Prilocaine

Cream (per g) 25mg/25mg

• Emla (AstraZeneca) originator
• Topla (Cipla Medpro)

Patch 25mg/25mg

• Emla (AstraZeneca) originator